Implantation or Injectable Dosage Form New Animal Drugs; Enrofloxacin, 22610-22611 [2011-9765]
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Federal Register / Vol. 76, No. 78 / Friday, April 22, 2011 / Rules and Regulations
1610. A continuing guaranty remains
valid for three years (and at such other
times as any change occurs in the legal
business status of the person filing the
guaranty).
B. Request To Accept, for Children’s
Product Certification Purposes, Tests
Pursuant to 16 CFR Part 1610
Conducted by Accredited Third Party
Laboratories Since August 18, 2009
III. The Response to the Requests
We have considered AAFA’s request
and, through this notice, are revising
our position regarding ‘‘Limited
Acceptance of Children’s Product
Certifications Based on Third Party
Conformity Assessment Body Testing
Prior to the Commission’s Acceptance of
Accreditation.’’ Due to the nature of the
wearing apparel industry, there is a
possible significant time lapse between
fabric testing and the finished garment.
This could mean that some products
that were tested previously by
laboratories that have since become
CPSC-accepted, would need to be
retested. Therefore, we agree that
revising our position on ‘‘retrospective’’
testing is appropriate because it will
reduce further the potential need for
redundant testing. We will accept
children’s product certifications based
on third party conformity assessment
body testing, prior to our acceptance of
accreditation, under the following
conditions:
• At the time of product testing, the
product was tested by a third party
conformity assessment body that was
ISO/IEC 17025 accredited by an
accreditation body that is a signatory to
the ILAC–MRA;
• The third party conformity
assessment body’s application for
testing using the test methods in 16 CFR
part 1610 is accepted by the CPSC on or
before November 16, 2010;
• The product was tested under 16
CFR part 1610 on or after August 18,
2009;
• The accreditation scope in effect for
the third party conformity assessment
body at the time of testing expressly
included testing to 16 CFR part 1610;
• The test results show compliance
with the applicable current standards
and/or regulations; and
• The third party conformity
assessment body’s accreditation,
including inclusion in its scope of 16
CFR part 1610, remains in effect through
the effective date for mandatory third
party testing and manufacturer
certification for conformity with 16 CFR
part 1610.
erowe on DSK5CLS3C1PROD with RULES
A. Request To Extend the Testing and
Certification Date by an Additional 60
Days
We decline to extend the date by
which a manufacturer of a children’s
product subject to 16 CFR part 1610
must have such product tested by a
third party conformity assessment body
accredited to do so and must issue a
certificate of compliance based on that
testing. We have the authority to grant
such a request only if there is
insufficient laboratory capacity. The
existence of 67 CPSC-accepted labs
accredited to test to 16 CFR part 1610
as of November 16, 2010, belies the
claim of insufficient laboratory capacity,
even if the laboratories are not
distributed geographically as the AAFA
would prefer.
We also disagree with the AAFA’s
assertion, as another basis for an
extension, that some manufacturers are
not fully aware that children’s product
certifications must be based on testing
conducted by CPSC-accepted third party
laboratories, and that many companies
are unaware that the stay of enforcement
on the testing and certification
requirements had been lifted for
children’s apparel. The CPSIA became
law in August 2008, and we published
the notice of requirements pertaining to
16 CFR part 1610 in the Federal
Register on August 18, 2010. The
statute’s existence, as well as the
publication of the notice of
requirements for 16 CFR part 1610,
provided notice of these manufacturers’
legal obligations. Additionally, the
Commission encourages the apparel and
textile trade associations to educate the
industry on their obligations under the
CPSIA and FFA.
Finally, we note that section
14(a)(3)(E) of the CPSA authorizes the
Commission to extend the deadline for
certification ‘‘by not more than 60 days.’’
Such a time period is measured from the
date on which such certification would
have been required. In this case, the
certification requirement became
effective for products manufactured
after November 16, 2010; therefore, a 60day extension, had it been granted,
would have expired in mid-January
2011. Thus, the AAFA’s request for an
extension is moot.
VerDate Mar<15>2010
14:51 Apr 21, 2011
Jkt 223001
Dated: April 19, 2011.
Todd A. Stevenson,
Secretary, Consumer Product Safety
Commission.
[FR Doc. 2011–9790 Filed 4–21–11; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 522
[Docket No. FDA–2011–N–0003]
Implantation or Injectable Dosage
Form New Animal Drugs; Enrofloxacin
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final rule.
The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect
approval of a supplemental new animal
drug application (NADA) filed by Bayer
HealthCare LLC. The supplemental
NADA provides for the addition of a
pathogen to the indications for use of
enrofloxacin solution in cattle, as a
single injection, for the treatment of
respiratory disease.
DATES: This rule is effective April 22,
2011.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Cindy L. Burnsteel, Center for
Veterinary Medicine (HFV–130), Food
and Drug Administration, 7500 Standish
Pl., Rockville, MD 20855, 240–276–
8341, e-mail:
cindy.burnsteel@fda.hhs.gov.
Bayer
HealthCare LLC, Animal Health
Division, P.O. Box 390, Shawnee
Mission, KS 66201, filed a supplement
to NADA 141–068 for BAYTRIL 100
(enrofloxacin), an injectable solution.
The supplemental NADA provides for
the addition of Mycoplasma bovis to the
pathogens in the indication for use of
enrofloxacin solution in cattle, as a
single injection, for the treatment of
bovine respiratory disease (BRD). The
supplemental NADA is approved as of
March 10, 2011, and the regulation in 21
CFR 522.812 is amended to reflect the
approval.
In accordance with the freedom of
information provisions of 21 CFR part
20 and § 514.11(e)(2)(ii), a summary of
safety and effectiveness data and
information submitted to support
approval of this application may be seen
in the Division of Dockets Management
(HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852, between 9
a.m. and 4 p.m., Monday through
Friday.
Under section 512(c)(2)(F)(iii) of the
Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360b(c)(2)(F)(iii)), this
supplemental approval qualifies for 3
SUPPLEMENTARY INFORMATION:
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22APR1
Federal Register / Vol. 76, No. 78 / Friday, April 22, 2011 / Rules and Regulations
years of marketing exclusivity beginning
on the date of approval.
The Agency has determined under 21
CFR 25.33 that this action is of a type
that does not individually or
cumulatively have a significant effect on
the human environment. Therefore,
neither an environmental assessment
nor an environmental impact statement
is required.
This rule does not meet the definition
of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because
it is a rule of ‘‘particular applicability.’’
Therefore, it is not subject to the
congressional review requirements in
5 U.S.C. 801–808.
DEPARTMENT OF THE TREASURY
List of Subjects in 21 CFR Part 522
ACTION:
Animal drugs.
Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
authority delegated to the Commissioner
of Food and Drugs and redelegated to
the Center for Veterinary Medicine, 21
CFR part 522 is amended as follows:
PART 522—IMPLANTATION OR
INJECTABLE DOSAGE FORM NEW
ANIMAL DRUGS
Internal Revenue Service
26 CFR Part 301
[TD 9518]
[FR Doc. 2011–9737 Filed 4–21–11; 8:45 am]
BILLING CODE 4830–01–P
RIN 1545–BJ52
Specified Tax Return Preparers
Required To File Individual Income Tax
Returns Using Magnetic Media;
Correction
Internal Revenue Service (IRS),
Treasury.
AGENCY:
Correction to final regulations.
This document describes a
correction to final regulations (TD 9518)
that were published in the Federal
Register on Wednesday, March 30, 2011
(76 FR 17521) providing guidance to
specified tax return preparers who
prepare and file individual income tax
returns using magnetic media pursuant
to section 6011(e)(3) of the Internal
Revenue Code.
SUMMARY:
This correction is effective on
April 22, 2011, and is applicable to
individual income tax returns filed after
December 31, 2010.
Authority: 21 U.S.C. 360b.
FOR FURTHER INFORMATION CONTACT:
2. In § 522.812, revise paragraph
(e)(2)(ii) to read as follows:
Keith L. Brau, (202) 622–4940 (not a
toll-free number).
§ 522.812
SUPPLEMENTARY INFORMATION:
■
Enrofloxacin.
*
*
*
*
(e) * * *
(2) * * *
(ii) Indications for use—(A) Singledose therapy: For the treatment of
bovine respiratory disease (BRD)
associated with Mannheimia
haemolytica, Pasteurella multocida,
Histophilus somni, and Mycoplasma
bovis in beef and non-lactating dairy
cattle.
(B) Multiple-day therapy: For the
treatment of bovine respiratory disease
(BRD) associated with Mannheimia
haemolytica, Pasteurella multocida, and
Histophilus somni in beef and nonlactating dairy cattle.
*
*
*
*
*
erowe on DSK5CLS3C1PROD with RULES
*
Dated: April 15, 2011.
Steven D. Vaughn,
Director, Office of New Animal Drug
Evaluation, Center for Veterinary Medicine.
[FR Doc. 2011–9765 Filed 4–21–11; 8:45 am]
BILLING CODE 4160–01–P
VerDate Mar<15>2010
14:51 Apr 21, 2011
Jkt 223001
amended by adding entries in numerical
order to read, in part, as follows:’’.
LaNita Van Dyke,
Chief, Publications and Regulations Branch,
Legal Processing Division, Associate Chief
Counsel (Procedure and Administration).
DATES:
1. The authority citation for 21 CFR
part 522 continues to read as follows:
■
22611
Background
The final regulations that are the
subject of this correction are under
section 6011 of the Internal Revenue
Code.
Need for Correction
As published, final regulations (TD
9518) contain an error that may prove to
be misleading and is in need of
clarification.
Correction of Publication
Accordingly, the publication of the
final regulations (TD 9518) which were
the subject of FR Doc. 2011–7571 is
corrected as follows:
On page 17528, column 2, under CFR
Part Heading ‘‘PART 301—PROCEDURE
AND ADMINISTRATION’’, the language
‘‘Par. 4. The authority citation for part
301 is amended by adding an entries in
numerical order to read, in part, as
follows:’’ is corrected to read ‘‘Par. 4.
The authority citation for part 301 is
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DEPARTMENT OF DEFENSE
Office of the Secretary
32 CFR Part 311
[Docket ID: DoD–2011–OS–0004]
Privacy Act of 1974; Implementation
Office of the Secretary, DoD.
Direct final rule with request for
comments.
AGENCY:
ACTION:
The Office of the Secretary of
Defense is exempting those records
contained in DMDC 12 DoD, entitled
‘‘Joint Personnel Adjudication System
(JPAS)’’, when investigatory material is
compiled solely for the purpose of
determining suitability, eligibility, or
qualifications for Federal civilian
employment, military service, Federal
contracts, or access to classified
information, but only to the extent that
such material would reveal the identity
of a confidential source.
This direct final rule makes
nonsubstantive changes to the Office of
the Secretary Privacy Program rules.
These changes will allow the
Department to add an exemption rule to
the Office of the Secretary of Defense
Privacy Program rules that will exempt
applicable Department records and/or
material from certain portions of the
Privacy Act. This change will allow the
Department to move part of the
Department’s personnel security
program records from the Defense
Security Service Privacy Program to the
Office of the Secretary of Defense
Privacy Program. This direct final rule
is consistent with the rule previously
published at 32 CFR 321.13(h) and
another rule is being published to
remove and reserve 321.13(h). This will
improve the efficiency and effectiveness
of DoD’s program by preserving the
exempt status of the applicable records
and/or material when the purposes
underlying the exemption(s) are valid
and necessary.
This rule is being published as a
direct final rule as the Department of
Defense does not expect to receive any
adverse comments, and so a proposed
rule is unnecessary.
SUMMARY:
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]]>Agencies
[Federal Register Volume 76, Number 78 (Friday, April 22, 2011)]
[Rules and Regulations]
[Pages 22610-22611]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-9765]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 522
[Docket No. FDA-2011-N-0003]
Implantation or Injectable Dosage Form New Animal Drugs;
Enrofloxacin
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect approval of a supplemental new animal drug
application (NADA) filed by Bayer HealthCare LLC. The supplemental NADA
provides for the addition of a pathogen to the indications for use of
enrofloxacin solution in cattle, as a single injection, for the
treatment of respiratory disease.
DATES: This rule is effective April 22, 2011.
FOR FURTHER INFORMATION CONTACT: Cindy L. Burnsteel, Center for
Veterinary Medicine (HFV-130), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 240-276-8341, e-mail:
cindy.burnsteel@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Bayer HealthCare LLC, Animal Health
Division, P.O. Box 390, Shawnee Mission, KS 66201, filed a supplement
to NADA 141-068 for BAYTRIL 100 (enrofloxacin), an injectable solution.
The supplemental NADA provides for the addition of Mycoplasma bovis to
the pathogens in the indication for use of enrofloxacin solution in
cattle, as a single injection, for the treatment of bovine respiratory
disease (BRD). The supplemental NADA is approved as of March 10, 2011,
and the regulation in 21 CFR 522.812 is amended to reflect the
approval.
In accordance with the freedom of information provisions of 21 CFR
part 20 and Sec. 514.11(e)(2)(ii), a summary of safety and
effectiveness data and information submitted to support approval of
this application may be seen in the Division of Dockets Management
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday.
Under section 512(c)(2)(F)(iii) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(iii)), this supplemental approval
qualifies for 3
[[Page 22611]]
years of marketing exclusivity beginning on the date of approval.
The Agency has determined under 21 CFR 25.33 that this action is of
a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.
This rule does not meet the definition of ``rule'' in 5 U.S.C.
804(3)(A) because it is a rule of ``particular applicability.''
Therefore, it is not subject to the congressional review requirements
in 5 U.S.C. 801-808.
List of Subjects in 21 CFR Part 522
Animal drugs.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs and
redelegated to the Center for Veterinary Medicine, 21 CFR part 522 is
amended as follows:
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
0
1. The authority citation for 21 CFR part 522 continues to read as
follows:
Authority: 21 U.S.C. 360b.
0
2. In Sec. 522.812, revise paragraph (e)(2)(ii) to read as follows:
Sec. 522.812 Enrofloxacin.
* * * * *
(e) * * *
(2) * * *
(ii) Indications for use--(A) Single-dose therapy: For the
treatment of bovine respiratory disease (BRD) associated with
Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and
Mycoplasma bovis in beef and non-lactating dairy cattle.
(B) Multiple-day therapy: For the treatment of bovine respiratory
disease (BRD) associated with Mannheimia haemolytica, Pasteurella
multocida, and Histophilus somni in beef and non-lactating dairy
cattle.
* * * * *
Dated: April 15, 2011.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. 2011-9765 Filed 4-21-11; 8:45 am]
BILLING CODE 4160-01-P
